Complaint, reporting and PMS leader

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Caesarea, Haifa District, Israel

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Complaint, Reporting & Post Market Surveillance (PMS) Leader to be in Caesarea

About the Role:
We are seeking a Complaint, Reporting & Post Market Surveillance (PMS) Leader to oversee all post-market quality activities for V-Wave. This role ensures compliance with global regulations and company procedures, driving excellence in complaint handling, vigilance reporting, and post-market surveillance.

Key Responsibilities:

Lead and manage the full lifecycle of complaint handling per FDA and EU MDR requirements.
Ensure timely product investigations and documentation.
Oversee vigilance and reporting activities, including regulatory submissions.
Trigger customer communications and escalations for safety issues or field actions.
Maintain compliance with EUMDR Article 83 and FDA CFR 21 P822 for PMS activities.
Monitor complaint trends and implement process improvements.
Provide training and guidance to the complaint team.
Lead updates to complaint processes for regulatory changes or new product launches.

Qualifications:

Scientific academic background (B.Sc. in Engineering preferred).
Minimum 5 years’ experience in medical device complaint handling.
Strong knowledge of GMP, FDA 820 QSR, EUMDR, ISO 13485.
Experience in Vigilance Reporting (EUMDR 2017/745) and MDR (FDA CFR 21 P803).
Advantage: Post Market Surveillance experience per EUMDR and FDA requirements.
Excellent English (written and verbal).

Why Join Us?
Be part of an international environment, ensuring patient safety and regulatory compliance while shaping post-market quality processes for innovative medical devices.

#LI-LM5

Required Skills:

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)